Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
NCT ID: NCT06228963
Last Updated: 2024-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2024-03-31
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib
Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) plus Orelabrutinib for 8 weeks (or until progression, intolerable toxicity, death, or withdrawal from the study)
Control group
Triple therapy for eradication of Helicobacter Pylori
Triple therapy for eradication of Helicobacter Pylori
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)
Interventions
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Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) plus Orelabrutinib for 8 weeks (or until progression, intolerable toxicity, death, or withdrawal from the study)
Triple therapy for eradication of Helicobacter Pylori
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed gastric mucosa-associated lymphoid tissue (MALT) lymphoma;
* Current infection with Helicobacter pylori (Hp): Diagnosis can be made if any of the following criteria are met: a) Positive result in at least one of the following: RUT (rapid urease test), histological staining, or bacterial culture of gastric mucosal tissue; b) Positive result in 13C or 14C-UBT (urea breath test); c) Positive result in HpSA detection. A positive result in serum Hp antibody test indicates past infection, and patients who have never been treated can be considered as having current infection.
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
* Lugano staging I-II1.
* Signed informed consent form.
* Evaluable lesions present.
Exclusion Criteria
* History of other tumors, except for cured cervical cancer or basal cell carcinoma of the skin;
* Patients with active HIV and syphilis infections;
* Pregnant or lactating women;
* Patients with severe active infections;
* Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
* Other comorbidities or conditions that may prevent patients from completing the clinical trial.
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Yizhen Liu
Clinical Professor
Principal Investigators
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Yizhen Liu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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iNHL-02
Identifier Type: -
Identifier Source: org_study_id
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